Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2020-02-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to test the safety of adding metformin to standard of care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments and radiation for 7 weeks.

Metformin is a medication that is currently used to treat diabetes. Increasing amounts of metformin will be given to groups of patients already receiving normal treatment for their cancer to see if metformin causes any good effects by killing your cancer or bad effects (side effects).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Cisplatin; Metformin

Criteria

Inclusion Criteria:

• Locally advanced squamous cell cancer of the head and neck, stage III or IV disease (T1-2, N2a-3 or T3-4).

• Measurable disease

• No prior chemotherapy or radiation for head and neck squamous cell cancer

• Life expectancy of greater than 3 months.

• Adequate labs

Exclusion Criteria:

• Known metastatic disease.

• Nasopharyngeal carcinoma

• History of allergic reactions attributed to metformin or other agents used in study.

• Known diagnosis of diabetes requiring insulin for control.

• Administration of metformin within last 4 weeks.